Clinical Research Nurse Coordinator ; RN

About this Job:

General Summary of Position

• Contributes to the achievement of established department goals and objectives and adheres to department policies procedures quality standards and safety standards. Complies with governmental and accreditation regulations.
• Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of and performing job functions in compliance with rules regulations policies and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with Med Star Health and Med Star Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner.
• Performs skills and duties that are within the scope of nursing practice with the ability to write orders with physician co-signature in the patient medical record (Med Connect). Incorporates the nursing process into holistic research participant care including clinical assessment to identify needs and problems experienced by participants and their caregivers.
• Facilitates site qualification study initiation and monitoring visits; works effectively with multidisciplinary ancillary and inter-professional research teams; possesses a basic understanding of scientific center goals and the importance of serving our customers. Participates in all audits and inspections and maintains the site in an audit-ready status.
• Assists and/or is responsible for the Institutional Review Board (IRB) submissions and other related regulatory forms; coordinates essential regulatory documents and submits timely and accurate regulatory documents to the Sponsor as applicable.
• Pre-screens potential research participants to determine initial eligibility and interest in a research study and adheres to guidelines to protect Protected Health Information (PHI).
• Conducts the research participant informed consent process according to MHRI consent policies and procedures and Good Clinical Practice. Ensures that the participant and family understand plan of care and health status implications and act as an advocate in meeting participant and family needs related to research protocol.
• Collects data pertinent to the research protocol requirements and the research participant’s health and/or situation. Assists the clinician/investigator in ensuring adequate source documentation and data-collection that validate the integrity of the clinical trial/research study. Documents participant encounters are updated as appropriate and within one (1) business day in a recognized electronic system/database (e.g. OnCore Clinical Trial Management System [CTMS]); enters data into various auditable databases or electronic data capture systems (e.g. REDCap).
• Implements the identified healthcare and research plans communicates effectively to all study personnel employs strategies to promote health and a safe environment and practices ethically and in a manner that is congruent with inclusion principles.
• Completes study required assessments using interview observation and physical examination (as appropriate) of participants consented for participation in research.
• Administers or provides oversight of administration of investigational product and other treatment agents or study interventions as appropriate.
• Maintains current Occupational Safety and Health Administration (OSHA) training regarding blood borne pathogens; maintains International Air and Transportation Association (IATA) training for routine packaging labeling and transporting of biological materials to ensure proper collection processing and shipment of biospecimens as needed.
• Receives and inventories test articles (study device or drug); works with research pharmacist as applicable; stores test articles according to Food and Drug Administration (FDA) regulations and Sponsor requirements; with oversight administers test articles; retrieves test articles and calculates research participant compliance as applicable; reconciles accountability log and completes research participant record.
• Understands and complies with rules…